Over-the-counter drug · UNAPPROVED HOMEOPATHIC
I-Sleep NDC 55714-2568
Wormwood 15 [hp_X]/mL + 24 more ingredients · Liquid · Oral · Newton Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55714-2568-1 | 5571425680155714256801 | 30 mL in 1 BOTTLE, GLASS (55714-2568-1)Marketed from Feb 1, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- I-Sleep
- Generic name (nonproprietary)
- absinthium, anacardium orientale, arg. nit., arsenicum alb., belladonna, bryonia, calc. carb., camphora, chamomilla, cimicifuga, cinchona, coffea cruda, cypripedium, gelsemium, humulus, hyoscyamus, ignatia, kali brom., nux vom., passiflora, pulsatilla, scutellaria lateriflora, sepia, thuja occ., valeriana
- Active ingredients
- Wormwood — 15 [hp_X]/mLSemecarpus anacardium juice — 15 [hp_X]/mLSilver nitrate — 15 [hp_X]/mLArsenic trioxide — 15 [hp_X]/mLAtropa belladonna — 15 [hp_X]/mLBryonia alba root — 15 [hp_X]/mLOyster shell calcium carbonate, Crude — 15 [hp_X]/mLCamphor (Natural) — 15 [hp_X]/mLMatricaria chamomilla — 15 [hp_X]/mLBlack cohosh — 15 [hp_X]/mLCinchona officinalis bark — 15 [hp_X]/mLArabica coffee bean — 15 [hp_X]/mLCypripedium parviflorum var. Pubescens root — 15 [hp_X]/mLGelsemium sempervirens root — 15 [hp_X]/mLHops — 15 [hp_X]/mLHyoscyamus niger — 15 [hp_X]/mLStrychnos ignatii seed — 15 [hp_X]/mLPotassium bromide — 15 [hp_X]/mLStrychnos nux-vomica seed — 15 [hp_X]/mLPassiflora incarnata flowering top — 15 [hp_X]/mLAnemone pulsatilla — 15 [hp_X]/mLScutellaria lateriflora whole — 15 [hp_X]/mLSepia officinalis juice — 15 [hp_X]/mLThuja occidentalis leafy twig — 15 [hp_X]/mLValerian — 6 [hp_X]/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Newton Laboratories, Inc.NDC labeler code 55714
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Dietary Proteins (Chemical structure)Food Additives (Chemical structure)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Plant Proteins (Chemical structure)Plant Proteins (Chemical structure)Plant Proteins (Chemical structure)Seed Storage Proteins (Chemical structure)Seed Storage Proteins (Chemical structure)
- Identifiers
- Product ID 55714-2568_c6a08953-15c4-797d-e053-2a95a90a7a0cSPL ID c6a08953-15c4-797d-e053-2a95a90a7a0cSPL set ID c6a08752-db62-2187-e053-2a95a90af138UNII F84709P2XV, Y0F0BU8RDU, 95IT3W8JZE, S7V92P67HO, WQZ3G9PF0H, T7J046YI2B, 2E32821G6I, N20HL7Q941, G0R4UBI2ZZ, K73E24S6X9, S003A158SB, 3SW678MX72, 21Y9GZ1LZA, 639KR60Q1Q, 01G73H6H83, 4WRK2153H3, 1NM3M2487K, OSD78555ZM, 269XH13919, CLF5YFS11O, I76KB35JEV, 7BP4DH5PDC, QDL83WN8C2, 1NT28V9397, JWF5YAW3QW
- Pharmacologic class
- Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455714256801followed by a unit qualifier and the quantityPackage 55714-2568-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE SECTION Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.
Excerpt only. Read the full label for complete information.
About NDC 55714-2568
- What is NDC 55714-2568?
- 55714-2568 is the product NDC for I-Sleep, Wormwood 15 [hp_X]/mL + 24 more ingredients liquid, listed with the FDA by Newton Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- I-Sleep (Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana).
- What is the active ingredient?
- Wormwood, Semecarpus anacardium juice, Silver nitrate, Arsenic trioxide, Atropa belladonna, Bryonia alba root, Oyster shell calcium carbonate, Crude, Camphor (Natural), Matricaria chamomilla, Black cohosh, Cinchona officinalis bark, Arabica coffee bean, Cypripedium parviflorum var. Pubescens root, Gelsemium sempervirens root, Hops, Hyoscyamus niger, Strychnos ignatii seed, Potassium bromide, Strychnos nux-vomica seed, Passiflora incarnata flowering top, Anemone pulsatilla, Scutellaria lateriflora whole, Sepia officinalis juice, Thuja occidentalis leafy twig, Valerian.
- Who is the labeler?
- Newton Laboratories, Inc., NDC labeler code 55714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for I-Sleep?
- 2 other product NDCs are listed under this name. See all I-Sleep NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other I-Sleep products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| I-Sleepabsinthium, anacardium orientale, arg. nit., arsenicum alb., belladonna, bryonia, calc. carb., camphora, chamomilla, cimicifuga, cinchona, coffea cruda, cypripedium, gelsemium, humulus, hyoscyamus, ignatia, kali brom., nux vom., passiflora, pulsatilla, scutellaria lateriflora, sepia, thuja occ., valeriana | Wormwood 15 [hp_X]/g + 24 more ingredients | PelletOral | Newton Laboratories, Inc. | 55714-2569 | 55714-2569-01 |
| I-Sleepabsinthium, anacardium orientale, arg. nit., arsenicum alb., belladonna, bryonia, calc. carb., camphora, chamomilla, cimicifuga, cinchona, coffea cruda, cypripedium, gelsemium, humulus, hyoscyamus, ignatia, kali brom., nux vom., passiflora, pulsatilla, scutellaria lateriflora, sepia, thuja occ., valeriana | Wormwood 20 [hp_X]/mL + 24 more ingredients | LiquidOral | Newton Laboratories, Inc. | 55714-4844 | 55714-4844-01 |